BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | April 24, 2023
PCI Pharma Services a leading global contract development and manufacturing organization announced that three new state-of-the-art automated sterile fill-finish machines at its San Diego and Melbourne facilities are now fully operational. The innovative machinery from Cytiva can be used to fill various sterile medications into vials and syringes for small-to-mid scale client needs. The equipment, paired with PCI’s end-to-end services, accelerates Speed to Study™, and drastically decreases the average turnaround time from proposal signing to the injectable product’s distribution.
“As the capacity for CDMOs worldwide to take on new projects shrinks, we’re excited to be able to offer integrated sterile fill-finish capabilities, alongside our clinical packaging facilities, to new and existing clients in Melbourne and San Diego,” said Brad Payne, Chief Operating Officer, PCI Pharma Services. “Our increased capacity, stockpile of standardized components, including glass, and technical expertise means we can start running batches as soon as needed. This will cut down on the wait times many pharmaceutical companies are facing and begin to help alleviate the global capacity shortage for sterile drug product and downstream packaging.”
The Microcell Vial Filler and SA25 Aseptic Filling Workcell at PCI’s San Diego facility ensures the delivery of medicines from phase I through phase III, supporting local and global Clinical client needs. Additionally, a Microcell Vial Filler at Melbourne further enhances the early-stage services offered and brings additional capacity to Australia—the world’s leading phase I environment. These advanced machines expedite the filling process with automation and remove the need for human intervention in a sterile environment, creating compliance advantages over standard equipment.
“There are less barriers to entry to start a clinical trial in Australia, as well as significant cost benefits, and with Melbourne being an especially popular place to conduct phase I trials, we knew we needed to bring this capability and added capacity to the local market,” said Tim Roberts, Chief Commercial Officer, PCI Pharma Services. “In addition, we are then able to take our clients through their lifecycle journeys with the expansions and advanced capabilities in our New Hampshire and Madison campuses. With successful recent inspections at our Bedford facility by the Brazilian (ANVISA) and Japanese (PDMA) regulatory authorities, our global reach to supply life-changing therapies to patients quickly and safely is wider than before.”
To better support its clients throughout the world, PCI has also recently invested in expansions in Rockford, IL, and Tredegar, Wales, as well as established new facilities in Bedford, NH, and Bridgewater, MA.
About PCI Pharma Services
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain) and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.
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BUSINESS INSIGHTS, PHARMA TECH
Hovione | March 21, 2023
Hovione, the specialist integrated CDMO, leader in spray drying and particle engineering, and Ripple Therapeutics, a leading ophthalmic sustained drug delivery company, have entered a strategic partnership to expand the use of Ripple's Epidel® platform beyond ophthalmic applications.
The core feature of Ripple's Epidel® technology is the ability to deliver sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. This enables higher drug loading, smaller size implants, defined and predictable biocompatible degradation products with straightforward and scalable manufacturing processes. Surface erosion-based drug release provides a highly effective way to control dose and duration. By incorporating Ripple's Epidel® platform into its toolbox, Hovione can expand its portfolio of novel drug delivery solutions to the pharmaceutical industry.
"The combination of technology synergy, innovative vision and cultural fit makes collaborating with Hovione an exciting next step in the advancement of the Epidel® platform beyond the ophthalmic field," stated Dr. Wendy Naimark, Ripple co-founder and Chief Technology Officer. "Hovione's expertise in controlled, sustained drug delivery, along with their experience in chemical synthesis and pharmaceutical manufacturing, makes for a great partnership."
"We are thrilled to partner with Ripple, who developed a state-of-the-art platform for sustained release," says Dr. Jean-Luc Herbeaux, Hovione's CEO. " Our shared goal is to accelerate and broaden the access to this highly innovative and enabling technology for the benefit of our pharmaceutical customers and their patients worldwide."
By extending the use of the Epidel® platform beyond ocular applications, this partnership will enable the development of a diverse range of new products with optimal sustained release profiles.
About Hovione
Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) with a fully integrated offering of services for drug substances, drug product intermediates and drug products. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione's culture is based on innovation, quality and dependability. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.
About Ripple Therapeutics
Ripple Therapeutics Corporation is a clinical stage, privately held company that is focused on ophthalmic therapeutics with controllable, sustainable drug delivery. The core feature of Ripple's Epidel™ technology is the ability to engineer sustained-release pharmaceuticals with surface erosion release kinetics without the use of polymers or excipients. Ripple's novel therapeutics provide for better outcomes for patients, easier management of care for physicians and lower costs for payors. Ripple has a full product pipeline in development.
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BUSINESS INSIGHTS, PHARMA TECH
Businesswire | April 26, 2023
Global healthcare and business consulting services provider, Terebellum, has chosen to adopt the name of its global parent, AscellaHealth, to reflect the scale of its operations and breadth of expertise.
The business specialises in providing end-to-end solutions to pharmaceutical manufacturers and other industry stakeholders to streamline product commercialisation, improve medication access, reduce costs and enhance patient outcomes for specialty and rare disease patients.
Based in Dublin, Ireland and Manchester, UK, former Terebellum provides pre-commercialisation and market access support, supply chain logistics, distribution and fulfilment and unique pharmaceutical financial services to UK and European pharmaceutical manufacturers and healthcare organisations.
Adopting the brand name of its parent company, AscellaHealth, will enable the specialty pharma expert to demonstrate its full range of expertise, international insight and distinctiveness of offer. Upon Terebellum’s transition to the AscellaHealth brand identity in its market-facing activities, the company will continue to maintain current business operations, client relationships and dedication to patient-centric care.
Craig Caceci, Managing Director at AscellaHealth EU/UK, said: “It’s our strong belief that to optimise outcomes in specialty healthcare a specialised approach is needed, due to the specific challenges associated with rare conditions.
“The AscellaHealth name provides an opportunity to highlight how we are perfectly positioned to offer uniquely tailored solutions across the globe to ensure streamlined medication access and the best possible treatment journey for rare and orphan disease patients.”
In a recent customer survey carried out by AscellaHealth, 100 percent of respondents agreed that the organisation presents unique value in the market and is uniquely qualified to address their needs.
Craig adds: “Supporting patients, life science manufacturers, payers and providers, we bring expertise and care to every requirement to develop and implement novel approaches that ensure patients with rare diseases can get the treatment they need, when they need it most.
“Our new brand tagline, ‘a rare and special perspective’, captures our dedication to applying knowledge and expertise to improve health outcomes of rare disease and specialty patients, perfectly.”
AscellaHealth, co-founded by Dea Belazi, President & CEO and Bill Oldham, Chairman & CFO in 2013, employs nearly 200 employees worldwide to provide integrated end-to-end solutions that span the entire pharmaceutical lifecycle and beyond, supporting all segments of the specialty pharma industry.
Former Terebellum joins US-based pharmacy distribution and patient-management organisation, Optime Care, in adopting the name of parent AscellaHealth, to form one globally-recognised brand for specialty pharma expertise.
About AscellaHealth LLC
AscellaHealth, a global Healthcare & Specialty Pharmacy solutions organisation, serving patients, life sciences manufacturers, payers, and providers, offers a comprehensive portfolio of uniquely tailored, tech-enabled services supporting complex, chronic conditions or rare diseases that require specialty medications and/or cell and gene therapies. A recipient of numerous industry awards for innovation, and a NASP Strategic Channel Partner of the Year award winner, AscellaHealth’s best-in-class, patient-centric approach is built upon proprietary technology processes for novel programs and services to support the launch of specialty medications and proactively address multiple challenges, optimise clinical health outcomes, and improve quality of life for this patient population. AscellaHealth brings a rare and special perspective to all stakeholders.
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